Eledon Pharmaceuticals Announces First Participant Dosed in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Rejection in Kidney Transplantation

Trial to assess potential of tegoprubart-based immunosuppression to improve graft function compared to tacrolimus-based immunosuppression

IRVINE, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the first participant has been dosed in the Company’s Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

BESTOW, a multicenter, two-arm, active comparator clinical study, will enroll approximately 120 participants undergoing kidney transplantation in the United States and other countries to evaluate the safety, pharmacokinetics, and efficacy of the anti-CD40 ligand antibody tegoprubart compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR) , in participants treated with tegoprubart compared to tacrolimus. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival.

Secondary objectives will include graft survival, biopsy-proven acute rejection, and the incidence of new onset diabetes mellitus after transplant. Eledon will also be using the iBox Scoring System, a composite endpoint of kidney graft function using clinical, histological, and serum biomarkers for the early prediction of graft failure, as an exploratory endpoint.

“We are excited to initiate enrollment in the Phase 2 BESTOW clinical trial, a critical next step in our evaluation of tegoprubart as a potential new immunosuppressive regimen to prevent rejection and improve graft function in patients receiving kidney transplants,” said David-Alexandre C. Gros, M.D., Eledon’s Chief Executive Officer. “This study aims to build on the growing body of evidence, including recently reported results from our Phase 1b trial, reinforcing our belief in the potential of tegoprubart to replace calcineurin inhibitors and provide kidney transplant recipients a much-needed alternative associated with better kidney function, reduced side effects and longer lifespans for transplanted organs. We look forward to generating further insights into the therapeutic potential of tegoprubart in comparison to the standard of care, while continuing to run our Phase 1b in parallel, positioning us to report multiple data updates over the next 18 months.”